Electrically Powered Wheelchair, Joy Rider

Wheelchair, Powered

Tung Keng Enterprise Co., Ltd.

The following data is part of a premarket notification filed by Tung Keng Enterprise Co., Ltd. with the FDA for Electrically Powered Wheelchair, Joy Rider.

Pre-market Notification Details

Device IDK220156
510k NumberK220156
Device Name:Electrically Powered Wheelchair, Joy Rider
ClassificationWheelchair, Powered
Applicant Tung Keng Enterprise Co., Ltd. No. 1, Lane 160, Sec. 2, Tan-Fu Road, Tan-Tzu Dist., Taichung City,  CN
ContactJen Ke-Min
CorrespondentJen Ke-Min
Roc Chinese-European Industrial Research Society No. 58, Fu Chiun Street Hsin Chu,  TW 30067
Product CodeITI  
CFR Regulation Number890.3860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-19
Decision Date2022-10-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719884540026 K220156 000
04719884540019 K220156 000

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